Actively Recruiting
A Phase I Study of SY-9453 in Patients With Advanced Solid Tumors
Led by Shouyao Holdings (Beijing) Co. LTD · Updated on 2026-04-27
122
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
Sponsors
S
Shouyao Holdings (Beijing) Co. LTD
Lead Sponsor
S
Shanghai East Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an open-label, single-arm, multicenter, dose-escalation and dose-expansion, phase I study to the safety, tolerability, pharmacokinetics, and preliminary efficacy of SY-9453 in patients with advanced solid tumors.
CONDITIONS
Official Title
A Phase I Study of SY-9453 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older who voluntarily consent to participate
- Histologically or cytologically confirmed locally advanced solid tumor with disease progression or intolerance to standard treatments, or no standard options available
- For dose escalation (30 mg and above) and dose expansion participants: confirmed homozygous deletion of the MTAP gene by NGS, IHC, or central lab testing
- At least one measurable extracranial lesion as defined by RECIST v1.1 or mRECIST v1.1 (except accelerated titration phase subjects)
- Expected survival longer than 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
- Organ functions meeting specific blood counts, renal, liver, and coagulation criteria
- Female patients with reproductive potential must have a negative pregnancy test within 7 days before first dose
- Male and female patients of childbearing potential must agree to use effective contraception during and for 3 months after the study
You will not qualify if you...
- Prior treatment with MAT2A inhibitor or PRMT5 inhibitor
- Allergy to any component of SY-9453 capsules
- Recent treatments before first dose including small-molecule targeted drugs, hormonal therapy, Chinese herbal medicines, radiotherapy, chemotherapy, investigational drugs, biotherapy, immunotherapy, major surgery, radioactive particle therapy, radionuclide therapy, or autotransplantation within specified timeframes
- Unresolved adverse events from prior anti-cancer therapies above Grade 1 (except certain low-risk toxicities)
- Other malignancies within 3 years except certain cured skin and cervical cancers
- Gastrointestinal disorders affecting drug absorption such as dysphagia, obstruction, Crohn's disease, ulcerative colitis, severe ulcers, perforation, or bleeding
- Active central nervous system disease unless stable and off steroids for at least 14 days
- Active hepatitis B or C, active syphilis, recent tuberculosis, HIV positive, or other immunodeficiency diseases
- Other underlying medical conditions posing risk or affecting toxicity assessment
- History of neurological or mental disorders such as dementia
- Significant heart, lung, or infection conditions, including poor heart function, arrhythmias, recent heart interventions, poorly controlled hypertension or diabetes, serious infections requiring therapy, or severe lung diseases
- Recent stroke or CNS bleeding
- History of organ or stem cell transplantation
- Use of CYP3A4 potent inhibitors or inducers within 2 weeks before first dose
- Pregnancy or breastfeeding
- Any other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai East Hospital
Shanghai, China
Actively Recruiting
Research Team
C
chen guang wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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